Synchronous versus metachronous brain metastasis from testicular germ cell tumors (TGCT): an analysis from the Spanish Germ Cell Cancer Group data base

BACKGROUND: Brain metastases of testicular germ cell tumor (TGCT) are a rare event. Prognostic is poor and there is not much evidence on optimal management of these patients. PATIENTS AND METHODS: A review of case records of germ cell tumor patients within the Spanish Germ Cell Cancer Group data base from 1994 to 2012 was conducted. RESULTS: Thirty-three out of 6,200 cases (0.5 %). Nineteen patients (57 %) group 1: synchronous, 13 (40 %) group 2: metachronous and only one developed brain metastasis during cisplatin-based chemotherapy (excluded from the analysis). Median serum BHCG levels at initial diagnosis was higher in group 1, whereas elevated AFP serum levels were more common in group 2. Histology in the primary tumor: chorionic carcinoma for group 1 versus embryonal carcinoma for group 2. Mainly solitary brain metastasis in group 2 (54 versus 21 %, respectively). The median overall survival from the diagnosis of central nervous system involvement was 16 months for group 1 (CI 95 % 13.9-18) and 23 months (95 % CI 0-165) for group 2 (log rank p = 0.84). Long-term survivors were practically identical in the two groups (38.9 % group 1 versus 38.5 % group 2). Regardless of the timing of brain metastasis, those patients that achieved complete response to the treatment had better survival (log rank p 0.003). CONCLUSION: Although some distinctive clinical characteristics have been found between patients with synchronous versus metachronous brain metastasis from TGCT, the timing of brain metastasis did not seem to have prognostic influence, but due to the retrospective nature of the analysis and the results should be interpreted with caution (AU)

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Synchronous versus metachronous brain metastasis from testicular germ cell tumors (TGCT): an analysis from the Spanish Germ Cell Cancer Group data base.

BACKGROUND: Brain metastases of testicular germ cell tumor (TGCT) are a rare event. Prognostic is poor and there is not much evidence on optimal management of these patients. PATIENTS AND METHODS: A review of case records of germ cell tumor patients within the Spanish Germ Cell Cancer Group data base from 1994 to 2012 was conducted. RESULTS: Thirty-three out of 6,200 cases (0.5 %). Nineteen patients (57 %) group 1: synchronous, 13 (40 %) group 2: metachronous and only one developed brain metastasis during cisplatin-based chemotherapy (excluded from the analysis). Median serum BHCG levels at initial diagnosis was higher in group 1, whereas elevated AFP serum levels were more common in group 2. Histology in the primary tumor: chorionic carcinoma for group 1 versus embryonal carcinoma for group 2. Mainly solitary brain metastasis in group 2 (54 versus 21 %, respectively). The median overall survival from the diagnosis of central nervous system involvement was 16 months for group 1 (CI 95 % 13.9-18) and 23 months (95 % CI 0-165) for group 2 (log rank p = 0.84). Long-term survivors were practically identical in the two groups (38.9 % group 1 versus 38.5 % group 2). Regardless of the timing of brain metastasis, those patients that achieved complete response to the treatment had better survival (log rank p 0.003). CONCLUSION: Although some distinctive clinical characteristics have been found between patients with synchronous versus metachronous brain metastasis from TGCT, the timing of brain metastasis did not seem to have prognostic influence, but due to the retrospective nature of the analysis and the results should be interpreted with caution.

Effectiveness of daily versus non-daily granulocyte colony-stimulating factors in patients with solid tumours undergoing chemotherapy: a multivariate analysis of data from current practice.

We conducted a multicentre, retrospective, observational study including patients with solid tumours (excluding breast cancer) that received granulocyte colony-stimulating factors (G-CSF) and chemotherapy. We investigated the effectiveness of daily vs. non-daily G-CSFs (pegfilgrastim) adjusting by potential confounders. The study included 391 patients (211 daily G-CSF; 180 pegfilgrastim), from whom 47.3% received primary prophylaxis (PP) (57.8% pegfilgrastim), 26.3% secondary prophylaxis (SP: initiation after cycle 1 and no reactive treatment in any cycle) (51.5% pegfilgrastim) and 26.3% reactive treatment (19.4% pegfilgrastim). Only 42.2% of patients with daily G-CSF and 46.2% with pegfilgrastim initiated prophylaxis within 72 h after chemotherapy, and only 10.5% of patients with daily G-CSF received it for ≥ 7 days. In the multivariate models, daily G-CSF was associated with higher risk of grade 3-4 neutropenia (G3-4N) vs. pegfilgrastim [odds ratio (OR): 1.73, 95% confidence interval (CI): 1.004-2.97]. Relative to SP, PP protected against G3-4N (OR for SP vs. PP: 6.0, 95%CI: 3.2-11.4) and febrile neutropenia (OR: 3.1, 95%CI: 1.1-8.8), and was associated to less chemotherapy dose delays and reductions (OR for relative dose intensity <85% for SP vs. PP: 3.1, 95%CI: 1.7-5.4) and higher response rate (OR: 2.1, 95%CI: 1.2-3.7). Data suggest that pegfilgrastim, compared with a daily G-CSF, and PP, compared with SP, could be more effective in preventing neutropenia and its related events in the clinical practice.

Cisplatin preparation error; patient management and morbidity.

INTRODUCTION: Antineoplastic drug therapy errors represent a high iatrogenic potential due to antineoplastic drugs narrow therapeutic ranges and the complexity of chemotherapy regimens that may increase the risk of morbidity and mortality for oncology patients. SETTING: We report a 57-year-old man with head and neck cancer who mistakenly received 180 mg/ m(2) of cisplatin overdose despite the safety measures and validations carried out during preparation. The patient developed moderate nausea and vomiting, acute renal failure, hearing difficulty (tinnitus), and severe myelodepression. PATIENT MANAGEMENT: Prophylactic and symptomatic treatments were applied in order to prevent and correct toxicity during the 9 days stay at hospital. RESULT: He recovered with mild tinnitus and mild renal impairment as the only sequelae. This case presents a hospital stay and treatment quite different to others used to reverse all cisplatin overdose toxicity and it shows the benefits of prompt management.

Prognostic value of the detection of lymph node micrometastases in colon cancer

INTRODUCTION AND OBJECTIVES: A study is made of the clinical repercussions of occult metastases-micrometastases (MMs+)-or isolated tumour cells (ITCs+) in the lymph nodes of patients with stage IIA and IIB colon adenocarcinoma initially considered as corresponding to N0. MATERIAL AND METHODS: A retrospective study of 39 patients with stage IIA and IIB (T3-T4 N0 M0) colon adenocarcinoma, subjected to similar surgical and adjuvant chemotherapy treatment, with long and careful follow-up (minimum: 5 years, mean: 81.7 months) was performed on their previously resected lymph nodes, with the aid of new histological and immunohistochemical (cytokeratin) sections, in order to detect MMs or ITCs. Disease-free survival (DFS) and global survival (GS) in the two groups (patients with MMs+ or ITCs+ vs. patients without MMs or ITCs) were compared at 5 years based on the corresponding Kaplan-Meier survival curves, with the Breslow test. RESULTS: A total of 382 lymph nodes from the 39 patients (mean: 9.8; standard deviation: 6.09) were revised. MMs+ were detected in 2 cases and ITCs+ in 2 more cases on the Cytokeratin study. GS of the whole series at 5 years was 89.74% (35 patients alive) with a DFS at 5 years of 79.49% (31 patients free of disease), but the 2 cases with MMs+ were dead at 5 years, with high statistical differences between both groups (MMs+/MMs-) (p<0.0001). When comparing the group of MMs+/ITCs+ patients and the group of MM-/ITCs- patients, the DFS and GS times at 5 years were higher in the MMs-/ITCs- group (p=0.0692 and p=0.006 respectively). CONCLUSIONS: Although the incidence of MMs+ or ITCs+ in the examined lymph nodes was low, the presence of MMs is related to a dramatic reduction in GS and DFS at 5 years. We encourage a detailed histological study of lymph nodes resected in patients with deep penetrating colon tumours in order to assure a pN0 status (AU)

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Carcinomatosis peritoneal mucinosa tratada con cisplatino (CDDP) intraperitoneal y 5-FU endovenoso / Mucinous peritoneal carcinomatosis treated with intraperitoneal cisplatin (CDDP) and intravenous 5-FU

• Propósito: describir el tratamiento de una entidad clínica poco frecuente de curso clínico variable.• Material y método: se presenta el caso de un paciente con carcinomatosis peritoneal mucinosa, varianteintermedia.• Resultados y conclusiones: una cirugía de citoreducción adecuada, seguida de quimioterapia conCDDP Intraperitoneal (IP) y 5FU ev, puede lograr una larga supervivencia en pacientes afectos de carcinomatosisperitoneal, con buena tolerancia al tratamiento

• Purpose: To describe the treatment of a slightly frequent clinical entity of variable clinical course.• Material and methods: We present the case of a patient with mucinous peritoneal carcinomatosis,intermediate variant.• Results and conclusion: A suitable cytoreductive surgery, followed by chemotherapy withintraperitoneal CDDP and intravenous 5-FU, can achieve a long survival of patients with peritonealcarcinomatosis, with good tolerance for the treatment

Adenocarcinoma colorrectal: factores pronósticos de supervivencia en el tratamiento adyuvante con 5-Fluorouracilo-Levamisol (5FU-Lev) / Colorectal adenocarcinoma: survical prognostic factors of the adjuvant treatment with 5-fluorouracil-levamisole (5FU-LEV)

- Propósito: Valoración de la supervivencia global (SG) y libre de enfermedad (SLE) a 5 años y estudio de los factores pronósticos de los pacientes operados, con finalidad curativa, de adenocarcinoma colorrectal estadios II y III, que recibieron tratamiento adyuvante con 5FU-LEV.- Material y métodos: ciento veintiséis pacientes tratados con esquema 5FU-LEV durante 12 meses, entre septiembre de 1990 y noviembre de 1997.- Resultados: La SG a los 5 años es de 68.3 por ciento y la SLE de 54 por ciento. El número de ganglios afectos por el tumor y la afectación vásculo-linfática y perineural, han resultado factores pronósticos significativos tanto en la SLE como en SG a los 5 años. La existencia de obstrucción intestinal tan sólo resulta factor pronóstico significativo en la SLE a los 5 años.- Conclusiones: los resultados que presentamos son semejantes a otras grandes series conocidas, tanto en supervivencia global y libre de enfermedad como en el estudio univariante de los factores pronósticos. La afectación ganglionar continúa presentando significación pronóstica con el análisis multivariante (AU)

A Bayesian method for predicting 5-fluorouracil pharmacokinetic parameters following short-term infusion in patients with colorectal cancer.

The objective of this study was to develop a population pharmacokinetic model and validate it using a Bayesian approach for predicting, a priori and a posteriori, the individual volume of distribution (V(d)) and clearance (Cl) of 5-fluorouracil (5-FU) given as short-term intravenous infusion in weekly and multiple doses. Forty-four patients were divided in group A (5-FU weekly doses) including 27 patients with nonmetastatic colorectal adenocarcinoma treated with 450 mg/m(2) of 5-FU, 1 day per week for 48 doses, plus oral levamisol (50 mg/8 h) for 3 days, every 15 days and group B (5-FU multiple doses) including 17 patients with metastatic colorectal adenocarcinoma, receiving 5-FU (425 mg/m(2)) plus intravenous folinic acid (20 mg/m(2)) over 5 consecutive days, every 4 weeks for six cycles. In both groups 5-FU was administered as a 30-60-min infusion. A total of 176 plasma concentrations were analyzed using a NONMEM program according to a linear one-compartment model. In group A, 5-FU population pharmacokinetic parameters were obtained and the covariables studied were age, gender, weight, ideal body weight, height, body surface area, creatinine clearance, and hepatic function tests. A priori and a posteriori validation of this model was carried out with plasma concentrations obtained in day 1 in group B. In group B, population pharmacokinetic parameters of 5-FU following multiple doses were estimated using scale factors to identify differences in 5-FU V(d) and Cl between days 1 and 4, and the interindividual, interoccasion, and residual variabilities studied. V(d) was 0.266 L/kg of ideal body weight and Cl was 1.21 L/h. kg of total weight following weekly doses. The plasma sample obtained at 10 min gave the best accuracy and precision predictions. When 5-FU was administered in multiple doses, the Cl of the drug in day 4 is reduced by 30.14% compared to day 1. The interoccasion variability was lower than interindividual variability for both V(d) and Cl, suggesting that it could be feasible to individualise dosage of 5-FU for subsequent cycles from data obtained in a previous one in an attempt to improve the therapeutic index of colorectal cancer treatment.

[Effect of the ingestion of food and gynecologic risk factors on breast cancer risk in Valencia]. / Influencia de la ingesta de alimentos y factores de riesgo ginecológicos en el riesgo de cáncer de mama en Valencia.

OBJECTIVES: The present case-control study was undertaken to elucidate the role of recent diet, specially in the influence of food groups, in the development of cancer of the breast. MATERIAL AND METHODS: A case-control study of breast cancer (BC) was conducted between April to November 1997 in Valencia (Spain). Cases were 65 women aged 35-78 years. Controls included 78 women aged 34-82. Dietary habits were investigated through a validated food frequency consumption questionnaire (FFQ) included 100 foods. One summary questions were included, concerning all food items of a certain type or food frequently consumption. The difference between variables was tested by the chi-square method. For each food item, quintiles of consumption were calculated by dividing the frequency distribution of the entire study group into 20th, 40th, 60th and 80th percentiles and multiple linear regression analysis were fitted to the data. To assess the independent associations between selected BC risk factors and BC stage. RESULTS: A significant trend of increasing risk with increasing intake emerged for the following food groups: Cereal dish (rice) (OR = 1.1; 95% CI: 0.1-10.0), poultry (OR = 6.0; 95% CI: 0.9-43.9), beef meat (OR = 1.3: 95% CI: 0.5-3.6) and high intake of some food groups exerted a significant protection against development of BC: eggs (OR = 0.6; 95% CI: 0.2-1.9), olive oil (OR = 0.5; 95% CI: 0.1-2.0), tomatoes (OR = 0.5; 95% CI: 0.1-1.8). When linear regression analyses was performed, consumption of tomatoes and parity showed an inverse association statistically significant with the stage of BC. CONCLUSIONS: Consumption of tomatoes, mainly, consumption of eggs and olive oil, and parity exhibited a statistically significant relationship (p < 0.05) with BC stage in Valencia (Spain).